Hospital Raja Permaisuri Bainun, Pharmacy Department, Ministry of Health Malaysia, Ipoh, Malaysia.
Hospital Raja Permaisuri Bainun, Clinical Research Centre, Ministry of Health Malaysia, Ipoh, Malaysia.
Med J Malaysia. 2023 Sep;78(5):602-608.
Previous trials and real-world studies have shown that nirmatrelvir/ritonavir (Paxlovid®) reduces hospitalisation and deaths in symptomatic, high-risk, nonsevere COVID-19 patients. However, there was a scarcity of data on its effectiveness in the local setting. This study aimed to determine the effectiveness of Paxlovid® in reducing hospitalisation and mortality among COVID-19 patients and to identify the types of adverse events that occur after taking Paxlovid®.
A two-arm prospective cohort study was conducted among adult patients with COVID-19 categories 2 and 3 treated with Paxlovid® and a matched control group. A standard risk-stratified scoring system was used to establish Paxlovid® eligibility. All patients who were prescribed Paxlovid® and took at least one dose of Paxlovid® were included in the study. The control patients were selected from a centralised COVID-19 patient registry and matched based on age, gender and COVID-19 stage severity.
A total of 552 subjects were included in the study and evenly allocated to the treatment and control groups. There was no statistically significant difference in 28-day hospitalisation after diagnosis [Paxlovid®: 26 (9.4%), Control: 34 (12.3%), OR: 0.74; 95%CI, 0.43-1.27; p=0.274] or all-cause death [Paxlovid®: 2 (0.7%), Control: 3 (1.1%), OR 1.51; 95%CI, 0.25-9.09; p=0.999]. There was no significant reduction in hospitalisation duration, intensive care unit admission events or supplementary oxygen requirement in the treatment arm. Ethnicity, COVID-19 severity at diagnosis, comorbidities and vaccination status were predictors of hospitalisation events.
In this two-arm study, Paxlovid® did not significantly lower the incidence of hospitalisation, all-cause death and the need for supplemental oxygen. Adverse effects were frequent but not severe. Paxlovid® efficacy varied across settings and populations, warranting further real-world investigations.
先前的试验和真实世界研究表明，尼马曲韦/利托那韦（帕克洛维）可降低有症状、高危、非重症 COVID-19 患者的住院率和死亡率。然而，关于其在当地环境中的有效性的数据很少。本研究旨在确定帕克洛维降低 COVID-19 患者住院率和死亡率的效果，并确定服用帕克洛维后发生的不良反应类型。
一项针对接受帕克洛维和匹配对照组治疗的 COVID-19 2 类和 3 类成人患者的双臂前瞻性队列研究。使用标准的风险分层评分系统来确定帕克洛维的资格。所有服用至少一剂帕克洛维的患者均被纳入研究。对照患者从中央 COVID-19 患者登记处选择，并根据年龄、性别和 COVID-19 严重程度进行匹配。
共有 552 名患者被纳入研究，并平均分配到治疗组和对照组。诊断后 28 天的住院率无统计学差异[帕克洛维：26（9.4%），对照组：34（12.3%），OR：0.74；95%CI，0.43-1.27；p=0.274]或全因死亡[帕克洛维：2（0.7%），对照组：3（1.1%），OR 1.51；95%CI，0.25-9.09；p=0.999]。治疗组的住院时间、入住重症监护病房事件或补充氧气需求没有显著减少。种族、诊断时 COVID-19 的严重程度、合并症和疫苗接种状况是住院事件的预测因素。
在这项双臂研究中，帕克洛维并未显著降低住院率、全因死亡率和补充氧气的需求。不良反应频繁但不严重。帕克洛维的疗效因环境和人群而异，需要进一步进行真实世界研究。
